To be successful, multi-month prescribing needs fine tuning

Shifts to less frequent clinic visits and medication pick-ups to free up healthcare resources and make life easier for people living with HIV are being implemented successfully in some African countries, but still need fine tuning, several studies presented at the 9th International AIDS Society Conference on HIV Science (IAS 2017) show.

The studies looked at the practice of multi-month prescribing, by which clinics provide several months of antiretroviral drugs at one time to people living with HIV in their care, in order to reduce the need for monthly clinic visits to pick up refills of medication.

Frequent clinic visits can be difficult to manage, especially if the clinic is a long way from home, transport is unaffordable or working hours prevent attendance at the clinic.

Less frequent clinic visits have been associated with better retention in HIV care in a large study in Zambia, and in other southern African countries, and also have the potential to reduce clinic congestion and increase the number of people who can be started on antiretroviral therapy (ART) as countries move to “Test and Treat” guidelines recommending treatment for all people living with HIV.

The practice of multi-month prescribing is central to the concept of differentiated care, through which people with less complex medical needs can receive more care in the community in order to free up medical resources for people who are sicker, those starting treatment and those with viral rebound.

Multi-month prescribing will not be suitable for everyone. In Malawi, for example, multi-month prescribing is offered to adults who have been on ART for at least six months, who have a viral load below 1000 copies/ml and good adherence. People with opportunistic infections or tuberculosis are required to attend the clinic more frequently. These criteria are designed to ensure that people with more complex clinical needs, and those who have recently started treatment, are not lost to follow-up.

But how does multi-month prescribing work out in practice? A survey of 30 health care facilities in Malawi shows that although two-thirds of people who are eligible for multi-month prescribing are receiving their medication in this way, so too are 42% of people who are not eligible for multi-month prescribing.

The survey, presented by Margaret Prust of the Clinton Health Access Initiative, looked at 75,364 people receiving treatment at 30 clinics in 2016 – 86% of patients were eligible and, of these, 73% were receiving multi-month prescribing. However, 42% of those ineligible for multi-month prescribing were receiving it too – approximately 5% of all patients. More than three-quarters of ineligible patients shifted to multi-month prescribing had detectable viral load above 1000 copies/ml and 39% of ineligible patients had not been on ART long enough to qualify.

A survey of health care workers and interviews with clinic managers explored the reasons for providing multi-month prescribing to patients who were not eligible. A lack of knowledge of the criteria for shifting patients to multi-month prescribing was a major reason for failing to offer multi-month prescribing or offering it to the wrong patients, but ineligible patients were also being moved to multi-month prescribing to reduce clinic workload or if they asked for it. Prust said that a need to travel to work far away from the clinic often motivated these requests.

Further training and job aids are needed for health care workers to help them to distinguish which patients are eligible, the study investigators concluded; better alignment of electronic and paper records would also ensure that health care workers have up-to-date information about viral load results, for example.

Although multi-month prescribing has been restricted largely to adults in Malawi, Baylor International Paediatric AIDS Initiative has been offering multi-month prescribing for children and adolescents at health care facilities in six African countries. So far, just over 15,000 children have been moved to multi-month prescribing and viral load suppression remains high. Only 1.8% of patients switched to multi-month prescribing have been lost to follow-up.

The study looked at the clinical outcomes of children and adolescents shifted to multi-month prescribing in Botswana, Lesotho, Swaziland, Malawi, Uganda and Tanzania. Children and adolescents were eligible for multi-month prescribing if they were clinically stable and adherent to ART, after six to nine months of monthly prescription pick-ups.

On average, children and adolescents shifted to multi-month prescribing attended the clinic every 61 days, compared to a mean interval of 39 days between visits for those on monthly prescribing. Patients who shifted to multi-month prescribing tended to have better long-term outcomes, as one would expect in a group of patients selected for the intervention on the basis of good short-term outcomes.

But, said Professor Maria Kim of Baylor Children’s Foundation, the take-home message of the study was that children continued to do well after switching to multi-month prescribing. The study found no differences in loss to follow-up between different age groups switched to multi-month prescribing, nor between countries.

Another model of reducing clinic visits is to devolve medication pick-up to adherence clubs in the community. A member can be assigned the responsibility to visit the clinic every two to three months to pick up medication for the other members of the club, or a nurse can attend the club to deliver drugs and draw blood for viral load testing. Members attend the club for counselling and to pick up their medication.

Community adherence clubs developed by Médecins Sans Frontières (MSF) in South Africa have shown promising results in observational studies.

Results of a two-year randomised study comparing community and clinic-based adherence clubs were presented by Colleen Hanrahan of Johns Hopkins Bloomberg School of Public Health, Baltimore. The study was carried out at Witkoppen Clinic in Johannesburg, South Africa, where 775 adults were randomised to attend a clinic- or community-based adherence club every two months.

The primary outcome of the study was the proportion of people in each study arm referred back to standard clinic-based care. Patients were referred back to standard clinic-based care if they missed a club visit without ART pick-up within 5 days, had two consecutive late ART pick-ups, developed a comorbidity requiring closer monitoring, or had viral load rebound. Women who became pregnant during the study were also referred back to the clinic.

The study population was approximately two-thirds female (65%) and had a high median CD4 cell count (506 cells/mm3). Participants were followed for two years. After two years, 57% of people in the clinic-based clubs were retained in care and had suppressed viral load compared to 47% in the community-based clubs (p = 0.003). The most common reasons for loss from club care and referral back to the clinic were missing a club visit and failing to pick up medication, and viral load rebound.

Abstract 1 Background: The provision of three-month antiretroviral (ARV) refills, or multi-month scripting (MMS), for stable HIV patients on antiretroviral therapy (ART) can increase service efficiency and decrease congestion. Since 2008, Malawi has offered MMS to patients that are 18 years or older, have been on ART at least six months, are on first-line ART, have no adverse drug reactions or opportunistic infections, have a viral load less than 1000 copies/mL, and have good adherence according to pill counts. We assessed the extent to which patients are accurately differentiated as eligible or ineligible for MMS and explored potential causes of inaccurate patient differentiation. Methods: Data were collected from 30 purposefully selected ART facilities in 2016. Participation and eligibility for MMS were determined based on 75,364 patient clinical records, which were analyzed using Stata version 13. Results were weighted and clustered by facility. The reasons for inaccurate patient differentiation were explored using structured surveys with 136 health workers and 32 qualitative interviews with clinic management. Interviews were audio recorded, transcribed and thematically coded. Results: A majority of patients (86.4%, 95% confidence interval [CI] 84.0-88.6) were eligible and 68.7% of patients (95% CI 62.5-74.6) were receiving MMS. Among patients eligible for MMS, 72.9% (95% CI 66.3-78.6) received MMS. However, 42.3% (95% CI 33.1-52.0) of ineligible patients (amounting to 5.7% of all patients) also received MMS. Results were similar based on sensitivity analyses using different eligibility criteria scenarios, but variation in the application of criteria existed across facilities. Among ineligible patients receiving MMS, 77% had viral load greater than 1000 copies/mL, and 39% had been on ART less than six months. Inaccurate patient differentiation was suggested to result from lack of health worker knowledge of the criteria for MMS, patient requests, health worker attempts to reduce workload, and perceived challenges with low stocks of medications. Conclusions: MMS is being widely implemented in Malawi, but patient differentiation in many facilities is not happening according to the agreed upon definition of eligibility. Simplification of guidance, improvements in health worker mentorship, patient counseling, and alignment of patient record forms against eligibility criteria would improve patient differentiation in Malawi.

Abstract 2 Background: To improve antiretroviral coverage (ART) and help reach the 90-90-90 treatment targets, differentiated approaches to care are necessary, including reduced frequency of clinic visits for stable patients. Given the paucity of data regarding the impact of differentiated care models on pediatric outcomes, BIPAI conducted a retrospective analysis of clinical outcomes, comparing monthly (MS) with multi-monthly (MMS) ART prescription schedules for children and adolescents in Botswana, Lesotho, Swaziland, Malawi, Uganda and Tanzania. Methods: MMS was introduced in each country in line with national policy. Patients were transferred to MMS when clinically stable and ART adherent, after 6-9 months of monthly prescriptions. For analysis patients were allocated to the MMS group after three consecutive visits at intervals of greater than 56 days. Adherence, lost-to-follow up rates, CD4 counts and viral load were compared between MS and MMS patients by two-sample tests for binomial proportions. Mortality was compared by log rank test. To avoid bias against the MS groups, deaths in the first 6 months of MS therapy were excluded, given the known, high early rates of mortality. To avoid immortal time bias, MMS patients contributed person-time to the MS group between ART initiation and the start of MMS. The analysis was conducted according to an IRB approved protocol. Results: There were 11,421 MS and 18,137 MMS patients aged between 0 and 19 years. Comparison of clinical outcomes is displayed in table 1. MMS patients had statistically lower mortality and lost-to-follow up rates, as well as superior ART adherence rates and response to ART by CD4 counts and viral load measurements. Conclusions: This study, representing data from six African countries, provides reassurance that patients 0-19 years of age who are clinically stable and ART adherent, can do well with reduced clinical visits via MMS. The consequent reduction in visits can yield additional benefits by decreasing the burden on health systems and patient time.

Abstract 3 Background: Adherence clubs, where groups of 25-30 patients stable on antiretroviral therapy (ART) meet for counselling and medication pick-up, is an innovative model to retain patients in care and facilitate task-shifting. Adherence clubs can be organized at a clinic or community venue. We performed a randomized controlled trial to compare club retention between community and clinic-based adherence clubs. Methods: Stable patients with undetectable viral load at Witkoppen Clinic in Johannesburg, South Africa, were randomized to a clinic- or community-based adherence club. Clubs were held every other month. All club participants received annual viral load monitoring and medical exam at the clinic. Patients were referred back to standard clinic-based care if they missed a club visit without ART pickup within 5 days, had two consecutive late ART pickups, developed a comorbidity requiring closer monitoring, or had viral rebound. We assessed the proportion referred back to routine care by 24 months following randomization. Results: From February 2014-May 2015, we randomized 775 adults into 12 pairs of clubs?376 (49%) clinic-based, and 399 (51%) community-based. Characteristics were similar by arm: 65% female, 89% on fixed-dose combination ART, and median CD4 count of 506 cells/mm3. The proportion referred back to standard clinic-based care was greater among community-based (47%, n=191) compared to clinic-based clubs (37%, n=140, p=0.003) (Figure). Adjusted for age, gender, employment and baseline CD4 count, community-based club participants had an increased risk of loss from club (aHR 1.43, 95% CI:1.15-1.79, p=0.001). Main reasons for return to clinic-based care were missing ART pickup (59%, n=198) or pregnancy (11%, n=36), and were similar by arm. Among those referred to standard care, 63% and 80% made a visit within 60 and 90 days respectively of their last club visit. Conclusions: By two years, drop-out from adherence club participation was high (43%) and higher among community-based compared to clinic-based clubs.

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